Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020706
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMADINE EMEDASTINE DIFUMARATE 0.05% SOLUTION/DROPS;OPHTHALMIC Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020706_emadine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/12/2003 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20706slr011ltr.pdf
12/04/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/20/1999 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/17/1999 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1999 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/04/1998 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/12/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20706slr011_emadine_lbl.pdf

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